Trials Sponsors Conditions Drugs Pricing

Conditions

Hypercholesterolemia Hypertriglyceridemia

Keywords

Prevention

Outcome Measures

Primary Outcomes (1)

Comparison between VAL070-B and placebo on changes between V1 and V2 visits of the fasting blood LDL cholesterol
Defined as the difference V2 (12 weeks) - V1 (baseline) in g/L
12 weeks

Secondary Outcomes (22)

Comparison between VAL070-A and placebo on changes between V1 and V2 visits of the fasting blood LDL cholesterol
12 weeks
Changes in fasting blood concentrations of triglycerides
12 weeks
Changes in fasting blood concentrations of total cholesterol
12 weeks
Changes in fasting blood concentrations of HDL cholesterol
12 weeks
Changes in fasting blood concentrations of non-HDL cholesterol
12 weeks
+17 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

The comparative product is a placebo with the same characteristics of appearance and packaging as studied products and in which all ingredients are replaced by maltodextrin.

Dietary Supplement: Placebo

VAL070-A

EXPERIMENTAL

Studied active product n°1, named VAL070-A, is a dietary supplement in shape of capsule. VAL070-A product contains 4 active plant extracts.

Dietary Supplement: VAL070-A

VAL070-B

EXPERIMENTAL

Studied active product n°2, named VAL070-B, is a dietary supplement in shape of capsule. VAL070-B product contains 5 active plant extracts.

Interventions

VAL070-ADietary supplement

After randomization (V1 visit), 8 capsules per day of VAL070-A during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.

VAL070-A

VAL070-BDietary supplement

After randomization (V1 visit), 8 capsules per day of VAL070-B during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age between 18 and 70 years (limits included),
BMI between 18.5 and 40 kg/m2 (limits included),

Sponsors & Collaborators

Valbiotis
Industrylead
Biofortis Mérieux NutriSciences
Othercollaborator

Study Sites (1)

Biofortis Mérieux NutriSciences Clinical Investigation Center

Saint-Herblain, 44800, France

MeSH Terms

Conditions

HypercholesterolemiaHypertriglyceridemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

David GENDRE, Dr
Biofortis Mérieux NutriSciences
PRINCIPAL INVESTIGATOR
Jean-Marie BARD, Dr-PhD
UFR des Sciences Pharmaceutiques et Biologiques, Nantes, France
STUDY CHAIR
Sébastien PELTIER, PhD
Valbiotis
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 8, 2016

First Posted

December 12, 2016

Study Start

January 2017

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2018

You may not qualify if:

Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal trouble or other metabolic disorder,
Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic or biliary disorders ongoing, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease),
With a history of ischemic cardiovascular event,
Having undergone recent surgical procedure (less than 6 months),
Suffering from an uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg),
With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient,
Pregnant or lactating women or intending to become pregnant within 3 months ahead,
For women: pregnancy or breastfeeding finished since less than 6 months,
Under cholesterol and/or lipid-lowering treatment (e.g. statins, fibrates, ezetimibe, bile acid sequestrants, niacin, etc.) or stopped less than 3 months before the V1 visit,
Requiring a cholesterol lowering by immediate pharmacologic intervention according to the current recommendations (AFSSAPS, 2005),
Under medication which could affect blood lipid parameters (e.g. long-term corticosteroid systemic drug, systemic antibodies, androgens or enzyme inducer, etc.) or stopped less than 3 months before the randomization (antihypertensive stable long-term treatment tolerated),
Regular intake of dietary supplements or "functional foods" which are known to have an impact on lipid metabolism (e.g. rich in plant stanol or sterol like PRO-ACTIV or DANACOL products, red yeast rice, policosanol, capsules containing omega-3 fatty acids from fish oils, containing beta glucanes, konjac extract or cinnamon, etc.) or stopped less than 3 months before the V1 visit,
Under treatment or dietary supplement which could significantly affect parameter(s) followed during the study according to the investigator or stopped in a too short period before the V1 visit,
With significant change in food habits or in physical activity in the 3 months before the V1 visit or not agreeing to keep them unchanged throughout the study,
With a current or planned in the next 3 months specific diet (hyper or hypocaloric, vegan, vegetarian...) or stopped less than 3 months before the study,
+15 more criteria

Effects of Two Herbal Dietary Supplements on Lipid Metabolism in Moderate Hypercholesterolemia and Hypertriglyceridemia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (22)

Study Arms (3)

Placebo

VAL070-A

VAL070-B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (22)

Study Arms (3)

Placebo

VAL070-A

VAL070-B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations